15

Nov

2007

2006 Edition, Cl lll Medtronic Paceart System

0

Company: Medtronic Inc. Cardiac Rhythm Management
Date of Enforcement Report:11/14/2007
Class:lll

PRODUCT
Medtronic Paceart System, 2006 Edition, The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices; Recall # Recall Number : Z-0081-2008

REASON
An issue with the Paceart System – 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting no episodes have occurred, instead of indicating that no data is available.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Minneapolis, MN, by letter on August 27, 2007.
Manufacturer: Medtronic Paceart, Arden Hills, MN. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
721 units

DISTRIBUTION
Nationwide

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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